UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053193 |
|---|---|
| Receipt number | R000060708 |
| Scientific Title | Moisturizing performance evaluation test of the scalp care products (in-bath treatment, out-bath scalp oil) |
| Date of disclosure of the study information | 2023/12/29 |
| Last modified on | 2023/12/22 10:34:50 |
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Basic information
Public title
Moisturizing performance evaluation test of the scalp care products (in-bath treatment, out-bath scalp oil)
Acronym
Moisturizing performance evaluation test of the scalp care products (in-bath treatment, out-bath scalp oil)
Scientific Title
Moisturizing performance evaluation test of the scalp care products (in-bath treatment, out-bath scalp oil)
Scientific Title:Acronym
Moisturizing performance evaluation test of the scalp care products (in-bath treatment, out-bath scalp oil)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check the moisturizing performance by measuring the water content of stratum corneum before and after applying the scalp care products (in-bath treatment, out-bath scalp oil).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The change rate of water content in the test site before and after applying the test products.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Single application of scalp massage treatment.Single application of cleansing treatment.Single application of scalp massage oil.Single application of water.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Male and female aged 20-59
Key exclusion criteria
1. Subjects with heart, lungs, kidney, liver, blood, endocrine, skin or other severe diseases.
2. Subjects suffering from skin diseases such as atopic dermatitis and contact dermatitis.
3. Subjects with any abnormalities (skin diseases, wounds, etc.) at the test site (inside of the forearm).
4. Subjects with have experience with allergies such as cosmetic rashes.
5. Subjects who participate in physically demanding investigations or participate (planned) in treatment.
6. Subjects deemed inappropriate to participate in this study by the principled investigator.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Yoshikawa |
Organization
Kao Corporation
Division name
Hair Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9526
yoshikawa.hayato@kao.com
Public contact
Name of contact person
| 1st name | Sana |
| Middle name | |
| Last name | Okada |
Organization
Kao Corporation
Division name
Hair Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9526
Homepage URL
okada.sana@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060708
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
